Acupuncture and Moxibustion Treatment for Crohn's Disease

Study Purpose

The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and mucosal immunity.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 16 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. meet the diagnostic criteria of Crohn's disease; 2. age 16-70 3. patients with mild or moderate CD (CDAI between 151 and 360); 4. not taking any medication or taking mesalazine, prednisone (dose ≤15mg and have taken at least one month), patients entered the study maintained the same dose unchanged; 5. did not taking immunosuppressive drugs or biological agents such as infliximab within 3 months before entering the study; 6. agreed and signed informed consent.

Exclusion Criteria:

1. pregnant or lactating patients; 2. associated with heart, brain, liver, kidney and hematopoietic system of serious diseases; 3. mental illness; 4. other serious diseases; 5. the presence of skin disease, fistula, sinus, mutilation and other conditions in the acupoints selected in the study that can not be implemented moxibustion treatment.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02559037

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOther
Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease
Additional Details

1. A randomized controlled trial. 2. Acupuncture and moxibustion treatment,placebo control. 3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease. 4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease. 5. To observe the effect on the regulation of mucosal immunity in Crohn's disease.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai, 200030

Site Contact

Chunhui Bao, PhD,MD

baochunhui789@126.com

862164395973

Nearest Location

Site Contact

Chunhui Bao, PhD,MD

baochunhui789@126.com

862164395973

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